U.S. patent application number 12/147462 was filed with the patent office on 2009-01-08 for method and structure for securing a monitoring device element.
This patent application is currently assigned to Abbott Diabetes Care, Inc.. Invention is credited to R. Curtis Jennewine, Marc B. Taub.
Application Number | 20090012377 12/147462 |
Document ID | / |
Family ID | 40222007 |
Filed Date | 2009-01-08 |
United States Patent
Application |
20090012377 |
Kind Code |
A1 |
Jennewine; R. Curtis ; et
al. |
January 8, 2009 |
METHOD AND STRUCTURE FOR SECURING A MONITORING DEVICE ELEMENT
Abstract
Structures and methods for attaching a device to a user's skin
are provided. Embodiments include refreshing an adhesive attaching
an element of an analyte monitoring device so that a first adhesive
attaches the element of the analyte monitoring device during a
first time period and a second adhesive attaches the element of the
analyte monitoring device to the user's skin during a second time
period. A sensor remains at least partially inserted into the
user's while the refreshing of the adhesive from the first to the
second adhesive occurs.
Inventors: |
Jennewine; R. Curtis; (San
Francisco, CA) ; Taub; Marc B.; (Mountain View,
CA) |
Correspondence
Address: |
JACKSON & CO., LLP
6114 LA SALLE AVENUE, #507
OAKLAND
CA
94611-2802
US
|
Assignee: |
Abbott Diabetes Care, Inc.
Alameda
CA
|
Family ID: |
40222007 |
Appl. No.: |
12/147462 |
Filed: |
June 26, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60946492 |
Jun 27, 2007 |
|
|
|
Current U.S.
Class: |
600/309 |
Current CPC
Class: |
A61B 5/6833 20130101;
A61B 5/14546 20130101; A61B 5/14865 20130101; A61B 5/14532
20130101; A61B 5/14514 20130101 |
Class at
Publication: |
600/309 |
International
Class: |
A61B 5/00 20060101
A61B005/00 |
Claims
1. A monitoring device element, comprising: a mount; a first
adhesive on a surface of the housing and adapted to secure the
mount to the skin for a first time period; and a second adhesive on
the surface of the housing and adapted to secure the mount to the
skin for a second time period.
2. The monitoring device element of claim 1, wherein the first
adhesive and the second adhesive are arranged in an alternating
pattern.
3. The monitoring device element of claim 2, wherein the
alternating pattern comprises alternating stripes.
4. The monitoring device element of claim 1, comprising at least
one protrusion attached to the first adhesive; wherein the first
adhesive is removable from the mount by pulling on the at least one
protrusion.
5. The monitoring device element of claim 1, comprising a removable
covering over the second adhesive; wherein when the removable
covering is removed, the second adhesive is exposed.
6. The monitoring device element of claim 5, further comprising at
least one protrusion attached to the removable covering so that the
removable covering is removed by pulling on a second
protrusion.
7. The monitoring device element of claim 1, wherein at least the
second adhesive is movable between a raised position and a lowered
position.
8. The monitoring device element of claim 7, wherein the second
adhesive is at the raised position during the first time period and
at the lower position during the second time period.
9. The monitoring device element of claim 1, further comprising: a
glucose sensor mounted on the mount; and at least one of a
transmitter, receiver or transceiver attached to the mount and
coupled to the sensor.
10. A method, comprising: inserting a sensor at least partially
into the skin, the sensor being supported by a sensor housing;
securing the sensor housing to the skin with a first adhesive
during a first time period; and securing the sensor housing to the
skin with a second adhesive during a second time period, the second
time period being after the first time period; wherein the sensor
remains at least partially inserted into the skin between the first
time period and the second time period.
11. The method of claim 10, further comprising removing a covering
to expose the second adhesive before securing the sensor housing to
the skin with the second adhesive.
12. The method of claim 10, further comprising removing the first
adhesive after the first time period.
13. The method of claim 10, further comprising: between said first
time period and said second time period, lifting the sensor housing
so that the first adhesive no longer contacts the skin; removing
the first adhesive to expose the second adhesive; and lowering the
sensor housing so that the second adhesive contacts the skin.
14. The method of claim 13, further comprising swiveling the sensor
housing before lowering the sensor housing so that the second
adhesive contacts the skin at a different location than the first
adhesive.
15. A monitoring device element, comprising: a sensor at least
partially inserted into skin; a sensor housing supporting the
sensor, the sensor housing comprising a sensor area and a hinged
area; a hinge hingedly connecting the sensor area and the hinged
area; and a first adhesive and a second adhesive layered on a
bottom surface of the hinged area; wherein the first adhesive is
adapted to secure the sensor housing to the skin during a first
time period and is removable; and further wherein removing the
first adhesive exposes the second adhesive, the second adhesive
being adapted to secure the sensor housing to the skin during a
second time period.
16. The monitoring device element of claim 15, further comprising a
partition between the first adhesive and the second adhesive;
wherein the first adhesive is removed and the second adhesive is
exposed by removing the partition.
17. The monitoring device element of claim 15, further comprising a
third adhesive at a bottom surface of the sensor area, the third
adhesive securing the sensor area to the skin.
18. The monitoring device element of claim 15, wherein the hinge
allows the hinged area to rotate away from the skin.
19. The monitoring device element of claim 15, wherein the hinge
allows the hinged area to swivel around the sensor area in a plane
substantially parallel to the skin.
20. A monitoring device element, comprising: a sensor adapted to be
at least partially inserted into skin; a housing which houses the
sensor; and a first adhesive and a second adhesive provided on a
bottom of the sensor housing and being adapted to secure the sensor
housing to a user's skin; wherein the first adhesive is stronger
than the second adhesive; and further wherein the first adhesive
and the second adhesive are formed in a pattern so that the first
adhesive contacts some areas of the skin and the second adhesive
contacts other areas of the skin.
21. The monitoring device element according to claim 20, wherein
the pattern comprises concentric circles.
22. The monitoring device element according to claim 20, wherein
the pattern comprises alternating stripes.
23. A monitoring device element comprising: a sensor adapted to be
at least partially inserted into skin; a housing which houses the
sensor; an adhesive provided on a bottom of the sensor housing and
being adapted to secure the sensor housing to a user's skin;
wherein a thickness of the adhesive varies.
24. A device element comprising: a sensor mount supporting a
sensor; a plurality of microneedles protruding from the sensor
mount and being adapted for insertion into a user's skin.
Description
RELATED APPLICATION
[0001] The present application claims priority under .sctn.35
U.S.C. 119(e) to U.S. provisional application No. 60/946,492 filed
Jun. 27, 2007 entitled "Method and Structure for Securing a
Monitoring Device Element," and assigned to the assignee of the
present application, Abbott Diabetes Care, Inc. of Alameda, Calif.,
the disclosure of which is incorporated by reference for all
purposes.
BACKGROUND
[0002] The detection of the level of analytes, such as glucose,
lactate, oxygen, and the like, in certain individuals is vitally
important to their health. For example, the monitoring of glucose
is particularly important to individuals with diabetes. Diabetics
may need to monitor glucose levels to determine when insulin is
needed to reduce glucose levels in their bodies or when additional
glucose is needed to raise the level of glucose in their
bodies.
[0003] Devices have been developed for continuous or automatic
monitoring of analytes, such as glucose, in bodily fluid such as in
the blood stream or in interstitial fluid. Some of these analyte
measuring devices are configured so that at least a portion of the
devices are positioned below a skin surface of a user, e.g., in a
blood vessel or in the subcutaneous tissue of a user.
[0004] The user's comfort and the range of activities that may be
performed while a portion of the device is positioned below a skin
surface are important considerations in designing extended-use
sensors for continuous or automatic in vivo monitoring of the level
of an analyte, such as glucose. There is a need for a small,
comfortable device which may continuously monitor the level of an
analyte, such as glucose, while still permitting the user to engage
in normal activities. Continuous and/or automatic monitoring of the
analyte may provide a warning to the user when the level of the
analyte is at or near a threshold level. For example, if glucose is
the analyte, then the monitoring device might be configured to warn
the user of current or impending hyperglycemia or hypoglycemia. The
user may then take appropriate actions.
[0005] One of the challenges associated with producing an effective
and comfortable monitoring device is securing an element of the
monitoring device to the skin. A monitoring device element may be
attached to the skin with an adhesive. However, adhesives
eventually lose their adhesive properties. Also, outer layers of
the skin continually slough off. Eventually, the loss of adhesion
and sloughing off of the skin serve to detach the monitoring device
element from the skin and the monitoring device element falls off
of the user.
[0006] When the monitoring device element falls off of the skin, a
new monitoring device element may have to be attached to the skin
and a new sensor may have to be inserted into the skin.
Accordingly, if a monitoring device falls off too quickly, its life
is limited and a user must insert another sensor, adding to the
cost of the monitoring device. Also, the more frequent insertions
of sensors may cause skin trauma.
[0007] One manner of increasing the attachment time is to provide a
stronger adhesive. However, increasing the strength of the adhesive
makes removal of the monitoring device element from the skin more
difficult and painful. Also, simply increasing the adhesive
strength may not overcome the problems associated with outer layers
of skin sloughing off the body. Accordingly, the present disclosure
is directed to providing a structure and method of attaching an
element of a monitoring device to a user's skin that will result in
a longer-lasting attachment.
SUMMARY
[0008] Provided are methods and structures for securing an element
of a monitoring device to a person's skin. In one embodiment a
first adhesive is used to secure the element to a person's skin
during a first time period and a second adhesive is used to secure
the element to the person's skin during a second time period. A
sensor may be at least partially inserted into the user's skin
during the first and the second time periods and the element may
include a housing for the sensor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The above aspects and features of the present disclosure
will be more apparent by describing certain embodiments of the
present disclosure with reference to the accompanying drawings, in
which:
[0010] FIG. 1 is a block diagram of an exemplary embodiment of a
data monitoring and management system according to the present
disclosure;
[0011] FIG. 2 shows a schematic diagram of an embodiment of an
analyte sensor according to the present disclosure; and
[0012] FIGS. 3A-3B show a perspective view and a cross sectional
view, respectively of another embodiment an analyte sensor.
[0013] FIG. 4 is a cross-sectional view of an exemplary embodiment
of an on-skin sensor unit, according to the disclosure;
[0014] FIG. 5 is a top view of a cover of the on-skin sensor unit
of FIG. 4;
[0015] FIG. 6 is bottom view of an on-skin sensor unit with
adhesives according to an exemplary embodiment of the present
disclosure;
[0016] FIG. 7 is a side view of the on-skin sensor unit of FIG.
6;
[0017] FIG. 8 is a side view of the on-skin sensor unit of FIG. 6
attached to a user's skin during a first time period;
[0018] FIG. 9 is a side view of the on-skin sensor unit of FIG. 6
attached to a user's skin during a second time period;
[0019] FIG. 10 is a side view of an on-skin sensor unit with
adhesives according to another exemplary embodiment of the present
disclosure and attached to a user's skin during a first time
period;
[0020] FIG. 11 is a side view of the on-skin sensor unit with
adhesives of FIG. 10 and attached to a user's skin during a second
time period;
[0021] FIG. 12 is a side view of an on-skin sensor unit with
adhesives according to another exemplary embodiment of the present
disclosure and attached to a user's skin during a first time
period;
[0022] FIG. 13A are side and perspective views, respectively, of
the on-skin sensor unit with adhesives shown in FIG. 12 with a
portion of the control unit lifted from the user's skin;
[0023] FIG. 14 is a bottom view of an on-skin sensor unit with
adhesives according to an exemplary embodiment of the present
disclosure;
[0024] FIG. 15 is a side view of an on-skin sensor unit with an
adhesive according to an exemplary embodiment of the present
disclosure.
[0025] FIG. 16 is a side view of an on-skin sensor unit with a
plurality of microneedles according to an exemplary embodiment of
the present disclosure.
DETAILED DESCRIPTION
[0026] Before the present disclosure is described, it is to be
understood that this disclosure is not limited to particular
embodiments described, as such may, of course, vary. It is also to
be understood that the terminology used herein is for the purpose
of describing particular embodiments only, and is not intended to
be limiting, since the scope of the present disclosure will be
limited only by the appended claims.
[0027] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limit of that range and any other stated or intervening
value in that stated range, is encompassed within the disclosure.
The upper and lower limits of these smaller ranges may
independently be included in the smaller ranges is also encompassed
within the disclosure, subject to any specifically excluded limit
in the stated range. Where the stated range includes one or both of
the limits, ranges excluding either or both of those included
limits are also included in the disclosure.
[0028] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this disclosure belongs.
Although any methods and materials similar or equivalent to those
described herein may also be used in the practice or testing of the
present disclosure, the preferred methods and materials are now
described.
[0029] It must be noted that as used herein and in the appended
claims, the singular forms "a", "an", and "the" include plural
referents unless the context clearly dictates otherwise.
[0030] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual embodiments
described and illustrated herein has discrete components and
features which may be readily separated from or combined with the
features of any of the other several embodiments without departing
from the scope or spirit of the present disclosure.
[0031] The figures shown herein are not necessarily drawn to scale,
with some components and features being exaggerated for
clarity.
[0032] Embodiments include analyte monitoring devices and systems
that include an analyte sensor--at least a portion of which is
positionable beneath the skin of the user--for the in vivo
detection, of an analyte, such as glucose, lactate, and the like,
in a body fluid. Embodiments include wholly implantable analyte
sensors and analyte sensors in which only a portion of the sensor
is positioned under the skin and a portion of the sensor resides
above the skin, e.g., for contact to a transmitter, receiver,
transceiver, processor, etc. The sensor may be, for example,
subcutaneously positionable in a user for the continuous or
periodic monitoring of a level of an analyte in a user's
interstitial fluid. For the purposes of this description,
continuous monitoring and periodic monitoring will be used
interchangeably, unless noted otherwise. The sensor response may be
correlated and/or converted to analyte levels in blood or other
fluids. In certain embodiments, an analyte sensor may be positioned
in contact with interstitial fluid to detect the level of glucose,
which detected glucose may be used to infer the glucose level in
the user's bloodstream. Analyte sensors may be insertable into a
vein, artery, or other portion of the body containing fluid.
Embodiments of the analyte sensors of the subject disclosure may be
configured for monitoring the level of the analyte over a time
period which may range from minutes, hours, days, weeks, or
longer.
[0033] Of interest are analyte sensors, such as glucose sensors,
that are capable of in vivo detection of an analyte for about one
hour or more, e.g., about a few hours or more, e.g., about a few
days of more, e.g., about three or more days, e.g., about five days
or more, e.g., about seven days or more, e.g., about several weeks
or at least one month. Future analyte levels may be predicted based
on information obtained, e.g., the current analyte level at time
t.sub.0, the rate of change of the analyte, etc. Predictive alarms
may notify the user of a predicted analyte levels that may be of
concern in advance of the user's analyte level reaching the future
level. This provides the user an opportunity to take corrective
action.
[0034] Embodiments described herein are applicable to attaching a
device to a person's skin. As noted above, the exemplary
embodiments described herein relate to attaching to a user's skin
an element of an analyte monitoring system using an implantable
sensor for the in vivo determination of a concentration of an
analyte, such as glucose or lactate, in a fluid. However, although
certain exemplary embodiments describe an analyte monitoring
system, the disclosure is not limited to the particular system
described herein. The structure and method of the present
disclosure may be applied to other devices and particularly to
devices adapted to be secured to a person's skin and also devices
which include a sensor which is at least partially inserted into
the person's skin.
[0035] FIG. 1 shows a data monitoring and management system such
as, for example, an analyte (e.g., glucose) monitoring system 100
in accordance with certain embodiments. Embodiments of the subject
disclosure are further described primarily with respect to glucose
monitoring devices and systems, and methods of glucose detection,
for convenience only and such description is in no way intended to
limit the scope of the disclosure. It is to be understood that the
analyte monitoring system may be configured to monitor a variety of
analytes at the same time or at different times.
[0036] Analytes that may be monitored include, but are not limited
to, acetyl choline, amylase, bilirubin, cholesterol, chorionic
gonadotropin, creatine kinase (e.g., CK-MB), creatine, creatinine,
DNA, fructosamine, glucose, glutamine, growth hormones, hormones,
ketone bodies, lactate, peroxide, prostate-specific antigen,
prothrombin, RNA, thyroid stimulating hormone, and troponin. The
concentration of drugs, such as, for example, antibiotics (e.g.,
gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of
abuse, theophylline, and warfarin, may also be monitored. In those
embodiments that monitor more than one analyte, the analytes may be
monitored at the same or different times.
[0037] The analyte monitoring system 100 includes a sensor unit
101, a data processing unit 102 connectable to the sensor unit 101,
and a primary receiver unit 104 which is configured to communicate
with the data processing unit 102 via a communication link 103. In
certain embodiments, the primary receiver unit 104 may be further
configured to transmit data to a data processing terminal 105 to
evaluate or otherwise process or format data received by the
primary receiver unit 104. The data processing terminal 105 may be
configured to receive data directly from the data processing unit
102 via a communication link which may optionally be configured for
bi-directional communication. Further, the data processing unit 102
may include a transmitter or a transceiver to transmit and/or
receive data to and/or from the primary receiver unit 104 and/or
the data processing terminal 105 and/or optionally the secondary
receiver unit 106.
[0038] Also shown in FIG. 1 is an optional secondary receiver unit
106 which is operatively coupled to the communication link and
configured to receive data transmitted from the data processing
unit 102. The secondary receiver unit 106 may be configured to
communicate with the primary receiver unit 104, as well as the data
processing terminal 105. The secondary receiver unit 106 may be
configured for bi-directional wireless communication with each of
the primary receiver unit 104 and the data processing terminal 105.
As discussed in further detail below, in certain embodiments the
secondary receiver unit 106 may be a de-featured receiver as
compared to the primary receiver, i.e., the secondary receiver may
include a limited or minimal number of functions and features as
compared with the primary receiver unit 104. As such, the secondary
receiver unit 106 may include a smaller (in one or more, including
all, dimensions), compact housing or embodied in a device such as a
wrist watch, arm band, etc., for example. Alternatively, the
secondary receiver unit 106 may be configured with the same or
substantially similar functions and features as the primary
receiver unit 104. The secondary receiver unit 106 may include a
docking portion to be mated with a docking cradle unit for
placement by, e.g., the bedside for night time monitoring, and/or a
bi-directional communication device. A docking cradle may recharge
a powers supply.
[0039] Only one sensor unit 101, data processing unit 102 and data
processing terminal 105 are shown in the embodiment of the analyte
monitoring system 100 illustrated in FIG. 1. However, it will be
appreciated by one of ordinary skill in the art that the analyte
monitoring system 100 may include more than one sensor unit 101
and/or more than one data processing unit 102, and/or more than one
data processing terminal 105. Multiple sensors may be positioned in
a user for analyte monitoring at the same or different times. In
certain embodiments, analyte information obtained by a first
positioned sensor may be employed as a comparison to analyte
information obtained by a second sensor. This may be useful to
confirm or validate analyte information obtained from one or both
of the sensors. Such redundancy may be useful if analyte
information is contemplated in critical therapy-related decisions.
In certain embodiments, a first sensor may be used to calibrate a
second sensor.
[0040] The analyte monitoring system 100 may be a continuous
monitoring system, or semi-continuous, or a discrete monitoring
system. In a multi-component environment, each component may be
configured to be uniquely identified by one or more of the other
components in the system so that communication conflict may be
readily resolved between the various components within the analyte
monitoring system 100. For example, unique IDs, communication
channels, and the like, may be used.
[0041] In certain embodiments, the primary receiver unit 104 may
include an analog interface section including and RF receiver and
an antenna that is configured to communicate with the data
processing unit 102 via the communication link 103, and a data
processing section for processing the received data from the data
processing unit 102 such as data decoding, error detection and
correction, data clock generation, data bit recovery, etc., or any
combination thereof.
[0042] In operation, the primary receiver unit 104 in certain
embodiments is configured to synchronize with the data processing
unit 102 to uniquely identify the data processing unit 102, based
on, for example, an identification information of the data
processing unit 102, and thereafter, to periodically receive
signals transmitted from the data processing unit 102 associated
with the monitored analyte levels detected by the sensor unit
101.
[0043] Referring again to FIG. 1, the data processing terminal 105
may include a personal computer, a portable computer such as a
laptop or a handheld device (e.g., personal digital assistants
(PDAs), telephone such as a cellular phone (e.g., a multimedia and
Internet-enabled mobile phone such as an iPhone or similar phone),
mp3 player, pager, and the like), drug delivery device, each of
which may be configured for data communication with the receiver
via a wired or a wireless connection. Additionally, the data
processing terminal 105 may further be connected to a data network
(not shown) for storing, retrieving, updating, and/or analyzing
data corresponding to the detected analyte level of the user.
[0044] The data processing terminal 105 may include an infusion
device such as an insulin infusion pump or the like, which may be
configured to administer insulin to users, and which may be
configured to communicate with the primary receiver unit 104 for
receiving, among others, the measured analyte level. Alternatively,
the primary receiver unit 104 may be configured to integrate an
infusion device therein so that the primary receiver unit 104 is
configured to administer insulin (or other appropriate drug)
therapy to users, for example, for administering and modifying
basal profiles, as well as for determining appropriate boluses for
administration based on, among others, the detected analyte levels
received from the data processing unit 102. An infusion device may
be an external device or an internal device (wholly implantable in
a user).
[0045] In certain embodiments, the data processing terminal 105,
which may include an insulin pump, may be configured to receive the
analyte signals from the data processing unit 102, and thus,
incorporate the functions of the primary receiver unit 104
including data processing for managing the user's insulin therapy
and analyte monitoring. In certain embodiments, the communication
link 103 as well as one or more of the other communication
interfaces shown in FIG. 1, may use one or more of: an RF
communication protocol, an infrared communication protocol, a
Bluetooth enabled communication protocol, an 802.11x wireless
communication protocol, or an equivalent wireless communication
protocol which would allow secure, wireless communication of
several units (for example, per HIPPA requirements), while avoiding
potential data collision and interference.
[0046] FIG. 2 schematically shows an embodiment of an analyte
sensor in accordance with the present disclosure. This sensor
embodiment includes electrodes 401, 402 and 403 on a base 404.
Electrodes (and/or other features) may be applied or otherwise
processed using any suitable technology, e.g., chemical vapor
deposition (CVD), physical vapor deposition, sputtering, reactive
sputtering, printing, coating, ablating (e.g., laser ablation),
painting, dip coating, etching, and the like. Materials include but
are not limited to aluminum, carbon (such as graphite), cobalt,
copper, gallium, gold, indium, iridium, iron, lead, magnesium,
mercury (as an amalgam), nickel, niobium, osmium, palladium,
platinum, rhenium, rhodium, selenium, silicon (e.g., doped
polycrystalline silicon), silver, tantalum, tin, titanium,
tungsten, uranium, vanadium, zinc, zirconium, mixtures thereof, and
alloys, oxides, or metallic compounds of these elements.
[0047] The sensor may be wholly implantable in a user or may be
configured so that only a portion is positioned within (internal) a
user and another portion outside (external) a user. For example,
the sensor 400 may include a portion positionable above a surface
of the skin 410, and a portion positioned below the skin. In such
embodiments, the external portion may include contacts (connected
to respective electrodes of the second portion by traces) to
connect to another device also external to the user such as a
transmitter unit. While the embodiment of FIG. 2 shows three
electrodes side-by-side on the same surface of base 404, other
configurations are contemplated, e.g., fewer or greater electrodes,
some or all electrodes on different surfaces of the base or present
on another base, some or all electrodes stacked together,
electrodes of differing materials and dimensions, etc.
[0048] FIG. 3A shows a perspective view of an embodiment of an
electrochemical analyte sensor 500 having a first portion (which in
this embodiment may be characterized as a major portion)
positionable above a surface of the skin 510, and a second portion
(which in this embodiment may be characterized as a minor portion)
that includes an insertion tip 530 positionable below the skin,
e.g., penetrating through the skin and into, e.g., the subcutaneous
space 520, in contact with the user's biofluid such as interstitial
fluid. Contact portions of a working electrode 501, a reference
electrode 502, and a counter electrode 503 are positioned on the
portion of the sensor 500 situated above the skin surface 510.
Working electrode 501, a reference electrode 502, and a counter
electrode 503 are shown at the second section and particularly at
the insertion tip 530. Traces may be provided from the electrode at
the tip to the contact, as shown in FIG. 3A. It is to be understood
that greater or fewer electrodes may be provided on a sensor. For
example, a sensor may include more than one working electrode
and/or the counter and reference electrodes may be a single
counter/reference electrode, etc.
[0049] FIG. 3B shows a cross sectional view of a portion of the
sensor 500 of FIG. 3A. The electrodes 510, 502 and 503, of the
sensor 500 as well as the substrate and the dielectric layers are
provided in a layered configuration or construction. For example,
as shown in FIG. 3B, in one aspect, the sensor 500, includes a
substrate layer 504, and a first conducting layer 501 such as
carbon, gold, etc., disposed on at least a portion of the substrate
layer 504, and which may provide the working electrode. Also shown
disposed on at least a portion of the first conducting layer 501 is
a sensing layer 508.
[0050] A first insulation layer such as a first dielectric layer
505 is disposed or layered on at least a portion of the first
conducting layer 501, and further, a second conducting layer 509
may be disposed or stacked on top of at least a portion of the
first insulation layer (or dielectric layer) 505. As shown in FIG.
3B, the second conducting layer 509 may provide the reference
electrode 502, and in one aspect, may include a layer of
silver/silver chloride (Ag/AgCl), gold, etc.
[0051] A second insulation layer 506 such as a dielectric layer in
one embodiment may be disposed or layered on at least a portion of
the second conducting layer 509. Further, a third conducting layer
503 may provide the counter electrode 503. It may be disposed on at
least a portion of the second insulation layer 506. Finally, a
third insulation layer may be disposed or layered on at least a
portion of the third conducting layer 503. In this manner, the
sensor 500 may be layered such that at least a portion of each of
the conducting layers is separated by a respective insulation layer
(for example, a dielectric layer). The embodiment of FIGS. 3A and
3B show the layers having different lengths. Some or all of the
layers may have the same or different lengths and/or widths
[0052] In certain embodiments, some or all of the electrodes 501,
502, 503 may be provided on the same side of the substrate 504 in
the layered construction as described above, or alternatively, may
be provided in a co-planar manner such that two or more electrodes
may be positioned on the same plane (e.g., side-by side (e.g.,
parallel) or angled relative to each other) on the substrate 504.
For example, co-planar electrodes may include a suitable spacing
there between and/or include dielectric material or insulation
material disposed between the conducting layers/electrodes.
Furthermore, in certain embodiments one or more of the electrodes
501, 502, 503 may be disposed on opposing sides of the substrate
504. In such embodiments, contact pads may be one the same or
different sides of the substrate. For example, an electrode may be
on a first side and its respective contact may be on a second side,
e.g., a trace connecting the electrode and the contact may traverse
through the substrate.
[0053] The description herein is directed primarily to
electrochemical sensors for convenience only and is in no way
intended to limit the scope of the disclosure. Other sensors and
sensor systems are contemplated. Such include, but are not limited
to, optical sensors, calorimetric sensors, and sensors that detect
hydrogen peroxide to infer glucose levels, etc. The sensor may be
used as part of the sensor unit 101.
[0054] At least some portions of the analyte monitoring system 100
may be attached on a user's skin. Exemplary embodiments of the
present disclosure are described with reference to the sensor unit
101 and the data processing unit 102 being attached to a user's
skin. However, other parts of the analyte monitoring system 100 may
additionally or alternatively be attached to a user's skin
[0055] FIGS. 4 and 5 show, respectively, an exemplary embodiment of
a sensor unit 101 and a data processing unit 102 which can be
coupled to a mount of the sensor unit 101. As shown in FIG. 4,
there is a sensor mount/housing 45 which stay on a user's skin
after the sensor is inserted into the user's skin. The sensor mount
45 holds the sensor 42 in place and hold the data processing
unit/transmitter 102. An adhesive portion 5 is provided on the
bottom of the sensor mount 45. As shown in FIG. 5, the data
processing unit 102 of the exemplary embodiment is a wireless
transmitter. The unit 102 includes tabs and guides which allow the
unit 102 to slide into the mount 45 and hold the transmitter 102 in
place. Additionally, the transmitter unit 102 comprises contact
points 80 which connect the sensor 42 to the transmitter. Together,
these units provide an on-skin unit 44.
[0056] The on-skin unit 44 may be formed in a shape that is
comfortable to the user and which may permit concealment, for
example, under a user's clothing. The thigh, leg, upper arm,
shoulder, or abdomen are convenient parts of the user's body for
placement of the on-skin sensor unit 44 to maintain concealment.
However, the on-skin unit 44 may be positioned on other portions of
the user's body. One embodiment of the on-skin sensor unit 44 has a
generally rectangular shape to enhance concealment, as illustrated
in FIGS. 4 and 5. However, other shapes and sizes, such as a thin
oval shape, may be used.
[0057] The particular profile, as well as the height, width,
length, weight, and volume of the on-skin unit 44 may vary and
depends, at least in part, on the components and associated
functions included in the on-skin sensor unit 44, as discussed
below. For example, in some embodiments, the on-skin unit 44 may
have a height of about 2 cm or less, 1.3 cm or less, or about 0.7
cm or less. In some embodiments, the on-skin unit 44 may have a
weight has a weight of about 90 grams or less, e.g., about 45 grams
or less, e.g., about 25 grams or less. In some embodiments, the
on-skin unit 44 has a volume of about 15 cm.sup.3 or less.
[0058] The sensor mount 45, illustrated in FIGS. 4 and 5, may be
formed using a variety of materials, including, for example,
plastic and polymeric materials, particularly rigid thermoplastics
and engineering thermoplastics. Suitable materials include, for
example, polyvinyl chloride, polyethylene, polypropylene,
polystyrene, ABS polymers, and copolymers thereof. The mount 45 may
be formed using a variety of techniques including, for example,
injection molding, compression molding, casting, and other molding
methods. Hollow or recessed regions may be formed in the sensor
mount 45 of the on-skin unit 44. The electronic components of the
on-skin unit 44, described below, and/or other items, such as a
battery or a speaker for an audible alarm, may be placed in the
hollow or recessed areas.
[0059] Conductive contacts 80 may be formed on the exterior of the
transmitter 102 which connect to the sensor 42.
[0060] FIGS. 6 and 7 show exemplary embodiments of the sensor unit
with a plurality of discrete adhesive portions on a surface, e.g.,
a bottom, of the sensor mount 45 for securing the on-skin unit 44
to a user's skin. FIG. 6 is a bottom view of the on-skin unit 44
and FIG. 7 is a cross-sectional side view of the on-skin unit 44.
The sizes of the adhesive portions may be exaggerated in the
drawings for purposes of explanation.
[0061] As shown in FIGS. 6 and 7, a first adhesive 1 and a second
adhesive 2 are provided on a bottom of the sensor mount 45. The
first adhesive 1 is used to secure the on-skin unit 44 to the
user's skin during a first time period and the second adhesive 2 is
used to secure the on-skin unit 44 to the user's skin during a
second time period. During the second time period, the first
adhesive may remain on the on-skin unit 44 and work with the second
adhesive or may be removed to expose the base of the sensor mount
45.
[0062] As shown in FIGS. 6 and 7, removable coverings 3 cover the
second adhesive 2 and optional protrusions 4 are attached to the
removable covering 3. The protrusions are used to help remove the
coverings 3 and expose a surface of the second adhesive 2. Since
the protrusions 4 are attached to the coverings 3, pulling on the
protrusions 4 removes the coverings 3. The protrusions 4 may be
thin strings. However, the protrusions are not limited to thin
strings, and other materials may be used to form the protrusions 4.
As shown in FIG. 6, a tab 5 may be attached to the protrusions 4.
The tab 5 allows for all of the coverings 3 to be removed at once
by pulling on the tab 5, rather than the individual protrusions 4.
The unit 44 remains on the user's skin during the time that the
second adhesive 2 is uncovered and used for attachment.
[0063] As noted above, after the second adhesive is exposed for
securing the on-skin unit 44, the first adhesive 1 may also be
removed. Accordingly, for example as shown in FIG. 6, protrusions 4
(or other contacts) if provided may also be attached to the first
adhesive 1. These protrusions 4 may also be attached to a tab 5 for
easier removal.
[0064] In FIGS. 6 and 7, the first and second adhesives are
patterned in the form of alternating stripes. This configuration
allows for a generally uniform distribution of the first and second
adhesive 1, 2. This configuration also allows for the coverings 3
of the second adhesive to be removed without disturbing the first
adhesive 1. Also, it allows the first adhesive 1 to be removed
without disturbing the second adhesive. The adhesives may be
arranged in other configurations as well. For example, other
configurations include, but are not limited to, dots, intersecting
stripes, etc.
[0065] FIGS. 8 and 9 illustrate a method of using of the adhesive
structure of FIGS. 6 and 7 to attach the on-skin unit 44 to a
user's skin according to certain embodiments. As shown in FIG. 8,
initially the first adhesive is exposed and the second adhesive is
covered by coverings 3. The first adhesive thus secures the sensor
to the skin S of a user for a first time period. This time period
may be any suitable period, e.g., approximately three days or
longer, e.g., approximately five days or longer, e.g.,
approximately seven days or longer, although the duration is not
particularly limited and may be substantially longer or shorter
than about three days.
[0066] At the end of the first time period, the coverings 3 are
removed. This may be done by pulling on the individual protrusions
4 or, if included, by pulling on a tab 5 attached to each of the
protrusions 4. The coverings 3 may also be removed in other manners
which do not require the protrusions 4 or tab 5. When the coverings
3 are removed, the second adhesive 2 is exposed to contact the
skin, and may be pressed on the skin S to maintain contact if
necessary. During the removal of the covering 3 and the pressing of
the second adhesive, the sensor 42 remains at least partially
inserted into the user's skin S, i.e., remains in analyte
monitoring position. While the coverings 3 are being removed, the
first adhesive may continue to secure the sensor mount 45 to the
user's skin.
[0067] As shown in FIG. 9, after the coverings 3 are removed, the
on-skin unit 44 may be pressed against the skin so that the fresh
second adhesive 2 attaches to the user's skin. The second adhesive
2 then secures the sensor unit to the user's skin for a second time
period. Again, this second time period is not particularly limited,
but may be analogous to that described above of the first time
period. The user may remove the sensor at the end of a specified
second time period, or the on-skin unit 44 may simply remain on the
user's skin until it falls off. In certain embodiments, third,
fourth, fifth, . . . adhesives may be included and the process may
be repeated as appropriate to extend the adhesion time to the
skin.
[0068] As shown in FIG. 9, after the second adhesive 2 is exposed
and helps secure the on-skin unit 44 to the skin S, the first
adhesive may be removed by the protrusions 4 and tab 5 described
above. Alternatively, the first adhesive 1 may simply remain on the
on-skin unit 44 during the second time period. If the first
adhesive 1 remains on the sensor mount 45, it may work in
conjunction with the second adhesive 2 during the second time
period.
[0069] Accordingly, according to the exemplary embodiment of FIGS.
8 and 9, the adhesive used to secure the on-skin unit 44 may be
refreshed or renewed without removing the sensor 42 from a user's
skin. Because the adhesive is refreshed, the on-skin unit 44 may
remain on the user's skin for a longer period of time without using
an unnecessarily strong adhesive. This may increase the life of the
on-skin unit 44 and the sensor 42 and may avoid unnecessary trauma
to the skin by excessive insertion of the sensor 42. Also, it may
avoid the inconvenience for the user of having to frequently
replace the sensor 42 and on-skin unit 44. The use of the multiple
adhesives as described in the exemplary embodiment may also
decrease the chances of an adverse reaction to the adhesives, since
the adhesive site may be changed between the use of the first and
second adhesives.
[0070] The first adhesive 1 and the second adhesive 2 may be the
same adhesive material or may be different adhesives, same or
different shape, size, etc. Also, they may have the same or
different strengths. For example, the first adhesive 1 may be made
stronger to ensure that the sensor mount 45 does not fall off
before the user exposes the second adhesive 2. The second adhesive
may be made less strong so that the user may comfortably remove the
sensor unit from the skin at the end of the second time period.
[0071] FIGS. 10 and 11 illustrate another exemplary embodiment of a
on-skin unit 44 attachment method and structure. FIG. 10 is a side
view of the on-skin unit 44 in a first configuration during a first
time period. Like the previous exemplary embodiment, there is both
a first adhesive 1 and a second adhesive 2. The first adhesive 1
secures the on-skin unit 44 to the user's skin S during the first
period and a fresh second adhesive 2 is used during a second time
period. As shown in FIG. 10, during the first time period, the
first adhesive 1 is at a lower position so that it may contact the
user's skin S and secure the sensor mount 45. As shown in FIG. 11,
after the first period, the second adhesive 2 is moved to a
position of contacting the skin and securing the sensor unit. This
may occur by switching the positions of the first and second
adhesives. Alternatively, the first adhesive 1 may be removed. In
any event, there may be a covering over the second adhesive 2 which
is removed before it is contacted with the skin S.
[0072] The positions of the first and second adhesives may be
changed in a variety of different ways. One possible manner is to
use a cam to press the areas of the first adhesives down during the
first time period and the second adhesives down during a second
time period. The areas of the sensor mount 45 may be biased in the
upward direction. Accordingly, when the cam is in a position of
pressing areas corresponding to the first or second adhesive
downwardly, the pressed areas move downward. When the first or
second adhesive is not pressed downward by a portion of the cam,
the adhesive returns up. Alternatively, the areas on which the
first and second adhesives are mounted may simply be mechanically
drivable up and down, but the turning of a gear or the like.
Mechanical methods may include a simple press-down on either side
of the device with a 2 pronged fork or a twisting action to rotate
an axle between a wheel/cylinder at either end of the device,
resembling the turn of a key. The motion may also be accomplished
in an electrical manner which provides similar mechanical movement
powered automatically by an attached motor. Other mechanical and
electrical methods for moving the first and second adhesives are
also possible.
[0073] FIGS. 12, 13A and 13B show another exemplary embodiment of
the disclosure. According to this exemplary embodiment, a first
adhesive 1 and a second adhesive 2 are layered on the bottom of the
on-skin unit 44. During the first time period, the sensor 42 is at
least partially inserted into the skin S and the sensor mount 45 of
the sensor unit is secured to the skin S by the first adhesive 1.
In this exemplary embodiment, the on-skin unit 44 includes a hinge
7. The hinge allows a hinged portion 51 of the on-skin unit 44 to
be hingedly rotated around a sensor portion 50 of the on-skin unit
44. As shown in FIG. 13A, after the first time period (e.g., three
days) has passed, hinge portion 51 may be rotated around the hinge
7. The sensor portion 50, which includes the sensor 42 remains in
the same location as the hinged portion 51 is lifted. Thus, the
sensor 42 may remain in the skin and functioning during this time.
After the hinged portion 51 is lifted, the first adhesive 1 is
removed and the second adhesive 2 is exposed. In FIG. 13B, the
hinged portion 51 is drawn in shadow to illustrate the hinge 7 in
further detail. As shown in FIG. 13B, in this exemplary embodiment
of the hinge 7, one leaf is attached to the sensor portion 50 and
another leaf is attached to the hinged portion 51 and the leaves
are connected at a corner portion of the sensor and hinge portions
50, 51 to allow the hinged portion 51 to rotate away from the
user's skin relative to the sensor portion 50. The disclosure is
not limited to the hinge shown in FIG. 13B and other types of
hinges and manners of hinging the hinged portion 51 to the sensor
portion 50 may also be used.
[0074] In this exemplary embodiment, a partition 8 is located
between the first adhesive 1 and the second adhesive 2. The
partition 8 separates the first 1 and second adhesive 2. The
partition 8 also serves as a covering for the second adhesive 2.
Removing the partition 8 peels off the first layer of adhesive 1
and exposes the second layer of adhesive 2. The hinged portion 51
may then be swiveled back around the hinge 7 so that the second
adhesive 2 contacts the skin S and secures the on-skin unit 44. In
this manner, the adhesive securing the on-skin unit 44 is refreshed
without disturbing the sensor 42.
[0075] Additionally, as shown in FIGS. 12, 13A and 13B, there may
be an area with no adhesive at an edge of the hinged portion. This
area of no adhesive helps to allow the hinged portion 51 to swivel
away from the skin S.
[0076] The on-skin unit 44 may be hinged and swiveled in various
directions. For example, instead of or in addition to being lifted
vertically away from the skin, the hinged portion 51 may be rotated
around the sensor 42. Rotating the location of the hinged portion
51 allows the second adhesive 2 to be attached to a fresh site, at
least partially different than the area of skin to which the first
adhesive 1 was attached. This helps to alleviate some of the
problems associated with the sloughing off of skin and may also
prevent problems associated with an adverse skin reaction to the
adhesive by lessening the time that the adhesive is attached to a
particular area of the skin.
[0077] Also, a sensor area adhesive 9 may be provided around the
sensor 42 at the sensor portion 50. The insertion of the sensor 42
itself provides at least some attachment to the skin. Also, the
sensor 42 may be provided with a barb or other structure to
increase its attachment in the skin S. The sensor area adhesive 9
provides an additional degree of attachment of the sensor portion
50 to the skin so that when the hinged portion 51 is being
swiveled, the sensor does not fall out of the user's skin. The
sensor area adhesive 9 may be stronger than the first and second
adhesives. Particularly, the sensor area adhesive 9 may be designed
to effectively last throughout the first and second time periods,
or at least through the first time period and the swiveling of the
hinged part 51.
[0078] The first and second adhesives 1, 2 may be either solid or
formed in a pattern such as stripes or concentric circles. Also,
the first and second adhesives may be the same adhesive or
different adhesives. For example, the first adhesive 1 may be made
stronger than the second adhesive 2 to ensure that it lasts until
the user exposes and uses the second adhesive 2. Alternatively, the
first adhesive 1 may be made less strong so that the user may
swivel the on-skin unit 44 away from the skin S.
[0079] According to another exemplary embodiment, shown in FIG. 14,
first and second adhesives 1, 2 are patterned on the bottom of the
on-skin unit 44 and are used at the same time to secure the on-skin
unit 44 to the user's skin. In this exemplary embodiment, the first
and second adhesives have different strengths and/or other
properties. For example, the first adhesive 1 may be stronger than
the second adhesive 2. The strong first adhesive would ensure that
the sensor mount 45 is strongly bonded to the user's skin while the
second adhesive 2 would also provide some assistance in securing
the on-skin unit 44, but would also balance comfort in removal.
Accordingly, this exemplary embodiment balances the characteristics
of the first adhesive 1 and the second adhesive 2.
[0080] The first and second adhesives 1, 2 may be arranged in a
striped manner. Another possibility is to arrange the first and
second adhesives 1, 2 in a pattern of concentric circles, as shown
in FIG. 14. These two patterns would allow a relatively good mixing
and spacing of the two different adhesives. However, the disclosure
is not limited to these two patterns.
[0081] FIG. 15 illustrates another exemplary embodiment. In this
exemplary embodiment only a first adhesive 1 is required, but the
thickness of the adhesive is varied over the surface of the on-skin
unit 44. For example, the adhesive is layered thickly at the lefts
side of the on-skin unit 44 and is increasingly thinly towards the
right side. Thickness is a factor in skin adhesion and the duration
which the adhesive may secure the sensor control device to a user's
skin. Therefore, varying the thickness of the adhesive over the
on-skin unit 44 allows for a balancing of the different
characteristics provided by different thicknesses.
[0082] Varying thicknesses of adhesive could also be used in the
exemplary embodiments with more than one adhesive. Also, the
different adhesive patterns disclose, including striped and
concentric circles, could be used in any of the exemplary
embodiments.
[0083] In another exemplary embodiment, shown in FIG. 16,
microneedles are used to help attach an on-skin unit 44 to the
user. As shown in FIG. 16, the microneedles 60 of the exemplary
embodiment protrude from a bottom surface of the sensor mount 45.
The microneedles help attach the on-skin unit 44 to the user by
being at least partially inserted into the user's skin. The
microneedles then catch or grab the user's skin, holding the
on-skin unit 44 in place. In FIG. 16 the microneedles 60 are shown
alone, without any adhesive. However, the microneedles 60 may also
be used in combination with an adhesive. The microneedles 60 may
protrude at an angle in the range of 45.degree. to 90.degree. with
respect to the sensor mount 45 in accordance with the desire for
balancing the strength of the attachment to the user's skin and the
ease of insertion and removal of the microneedles 60 from the
user's skin.
[0084] The on-skin unit 44 described in the above exemplary
embodiments is not particularly limited. In the exemplary
embodiments, the on-skin unit 44 comprises a sensor 42 and sensor
mount 45 to which a transmitter 102 is coupled. However, the
on-skin unit adhered to the user's skin may include elements other
than those shown in the exemplary embodiments. For example, the
on-skin unit 44 may comprise only a sensor. Alternatively, the
on-skin unit 44 could include a variety of other components which
are part of an analyte monitoring system or other system.
[0085] Also, the exemplary embodiment of the disclosure have been
described with respect to an on-skin unit 44 for use with an
analyte monitoring system 100. However, the attachment structure
and methods described above may be applied to any of a variety of
objects and devices which need to be secured, particularly those
objects which need to be secured to someone's skin and which
include a sensor or other device which should remain in the same
place throughout an attachment. For example, the securement
structures and methods described above could be applied to
additional or alternative portion of the analyte monitoring system
100. That is, in another embodiment all of the elements of the
sensor control element 101 of the analyte monitoring system 100
would not necessarily have to be located on the user's skin. The
present disclosure could be applied to an inserted sensor without a
transmitter 102. Furthermore, the attachment methods and structures
described above could be applied to devices other than elements of
an analyte monitoring system such as an on-body insulin patch or
infusion set/cannula of a pump system, or the drug delivery patch
of another type of drug delivery system, for example for pain
medication, birth control, depression, etc. Particularly, devices
for attachment to a person's skin. These devices may include at
least a portion of an element, such as a sensor, inserted into a
person's skin.
[0086] A monitoring device element in on embodiment includes a
mount, a first adhesive on a surface of the housing and adapted to
secure the mount to the skin for a first time period, and a second
adhesive on the surface of the housing and adapted to secure the
mount to the skin for a second time period.
[0087] The first adhesive and the second adhesive may be arranged
in an alternating pattern, where the alternating pattern may
include alternating stripes.
[0088] The monitoring device element may include at least one
protrusion attached to the first adhesive, where the first adhesive
is removable from the mount by pulling on the at least one
protrusion.
[0089] In another aspect, the monitoring device element may include
a removable covering over the second adhesive, where when the
removable covering is removed, the second adhesive is exposed.
[0090] The monitoring device element may include at least one
protrusion attached to the removable covering so that the removable
covering is removed by pulling on a second protrusion.
[0091] In another aspect, at least the second adhesive may be
movable between a raised position and a lowered position, where the
second adhesive may be at the raised position during the first time
period and at the lower position during the second time period.
[0092] The monitoring device element in still another aspect
includes a glucose sensor mounted on the mount, at least one of a
transmitter, receiver or transceiver attached to the mount and
coupled to the sensor.
[0093] A method in another aspect includes inserting a sensor at
least partially into the skin, the sensor being supported by a
sensor housing, securing the sensor housing to the skin with a
first adhesive during a first time period, and securing the sensor
housing to the skin with a second adhesive during a second time
period, the second time period being after the first time period,
where the sensor remains at least partially inserted into the skin
between the first time period and the second time period.
[0094] The method may include removing a covering to expose the
second adhesive before securing the sensor housing to the skin with
the second adhesive.
[0095] In another aspect, the method may include removing the first
adhesive after the first time period.
[0096] Also, the method may include, between said first time period
and said second time period, lifting the sensor housing so that the
first adhesive no longer contacts the skin, removing the first
adhesive to expose the second adhesive, and lowering the sensor
housing so that the second adhesive contacts the skin.
Additionally, the method may include swiveling the sensor housing
before lowering the sensor housing so that the second adhesive
contacts the skin at a different location than the first
adhesive.
[0097] A monitoring device element in accordance with another
aspect of the present disclosure includes a sensor at least
partially inserted into skin, a sensor housing supporting the
sensor, the sensor housing comprising a sensor area and a hinged
area, a hinge hingedly connecting the sensor area and the hinged
area, and a first adhesive and a second adhesive layered on a
bottom surface of the hinged area, where the first adhesive is
adapted to secure the sensor housing to the skin during a first
time period and is removable, and where removing the first adhesive
exposes the second adhesive, the second adhesive being adapted to
secure the sensor housing to the skin during a second time
period.
[0098] The monitoring device element may include a partition
between the first adhesive and the second adhesive, where the first
adhesive is removed and the second adhesive is exposed by removing
the partition.
[0099] In one aspect, the monitoring device element may include a
third adhesive at a bottom surface of the sensor area, the third
adhesive securing the sensor area to the skin.
[0100] The hinge in one aspect may allow the hinged area to rotate
away from the skin.
[0101] In another aspect, the hinge may allow the hinged area to
swivel around the sensor area in a plane substantially parallel to
the skin.
[0102] A monitoring device element in accordance with another
aspect may include a sensor adapted to be at least partially
inserted into skin, a housing which houses the sensor, a first
adhesive and a second adhesive provided on a bottom of the sensor
housing and being adapted to secure the sensor housing to a user's
skin, where the first adhesive is stronger than the second
adhesive, and further, where the first adhesive and the second
adhesive are formed in a pattern so that the first adhesive
contacts some areas of the skin and the second adhesive contacts
other areas of the skin.
[0103] The pattern may include concentric circles, or alternating
stripes.
[0104] A monitoring device element in still another aspect may
include a sensor adapted to be at least partially inserted into
skin, a housing which houses the sensor, an adhesive provided on a
bottom of the sensor housing and being adapted to secure the sensor
housing to a user's skin, where a thickness of the adhesive
varies.
[0105] A device element in still yet another aspect includes a
sensor mount supporting a sensor, a plurality of microneedles
protruding from the sensor mount and being adapted for insertion
into a user's skin.
[0106] Accordingly, while non-limiting exemplary embodiments of the
disclosure have been described and illustrated above, it should be
understood that these are examples of the disclosure and are not to
be considered as limiting. It will be understood by those of
ordinary skill in the art that additions, omissions, substitutions,
and other modifications may be made without departing from the
spirit or scope of the present disclosure.
* * * * *